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Sodium Fluoride. November 20, 1997. Requirements for Child-Resistant Packaging. Federal Register.
http://www.epa.gov/fedrgstr/EPA-TOX/1997/November/Day-20/t30555.htm
[Federal Register: November 20, 1997 (Volume 62, Number 224)]
[Proposed Rules]
[Page 61928-61933]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20no97-16]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
Requirements for Child-Resistant Packaging; Household Products
With More Than 50 mg of Elemental Fluoride and More Than 0.5 Percent
Elemental Fluoride; and Modification of Exemption for Oral Prescription
Drugs With Sodium Fluoride
AGENCY: Consumer Product Safety Commission.
ACTION: Proposed rule.
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SUMMARY: The Commission is proposing a rule to require child-resistant
(``CR'') packaging for household products containing more than the
equivalent of 50 mg of elemental fluoride and more than the equivalent
of 0.5 percent elemental fluoride (on a weight-to-volume (``w/v'') or
weight-to-weight (``w/w'') basis). Examples of such products are some
rust removers, toilet cleaners, metal cleaners and etching products.
Dental products, such as toothpaste, contain lower levels of fluoride
and would not be affected. For consistency, the Commission is also
proposing to modify the oral prescription drug exemption for sodium
fluoride preparations. Instead of allowing drugs with no more than 264
mg of sodium fluoride per package to be in non-CR packaging as the
current rule does, the Commission proposes to allow such drugs with
only 50 mg or less of the equivalent of elemental fluoride (110 mg or
less of sodium fluoride) per package and no more than the equivalent of
0.5 percent elemental fluoride on a w/v or w/w basis. The Commission
has preliminarily determined that child-resistant packaging is
necessary to protect children under 5 years of age from serious
personal injury and serious illness resulting from handling or
ingesting a toxic amount of elemental fluoride. The Commission takes
this action under the authority of the Poison Prevention Packaging Act
of 1970.
DATES: Comments on the proposal should be submitted no later than
February 3, 1998.
ADDRESSES: Comments should be mailed to the Office of the Secretary,
Consumer Product Safety Commission, Washington, D.C. 20207, or
delivered to the Office of the Secretary, Consumer Product Safety
Commission, Room 502, 4330 East-West Highway, Bethesda, Maryland 20814-
4408, telephone (301)504-0800. Comments may also be filed by
telefacsimile to (301) 504-0127 or by email to cpsc-os@cpsc.gov.
FOR FURTHER INFORMATION CONTACT: Jacqueline Ferrante, Ph.D., Division
of Health Sciences, Directorate for Epidemiology and Health Sciences,
Consumer Product Safety Commission, Washington, D.C. 20207; telephone
(301)504-0477 ext. 1199.
SUPPLEMENTARY INFORMATION:
A. Background
1. Household Products Containing Fluoride
Many types of household products may contain fluoride in one form
or another. Fluorides are ingredients in cleaning products for metal,
tile, brick, cement, wheels, radiators, siding, toilets, ovens and
drains. Fluorides are also found in rust and water stain removers,
silver solder and other welding fluxes, etching compounds, laundry
sour, air conditioner coil cleaners and floor polishes. The fluorides
that may be ingredients in these products and are potentially toxic are
hydrofluoric acid (``HF''), ammonium bifluoride, ammonium fluoride,
potassium bifluoride, sodium bifluoride, sodium fluoride and sodium
fluosilicate.<SUP>1</SUP> [3] <SUP>2</SUP>
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\1\ The percentage of elemental fluoride in any compound is
determined by dividing the molecular weight of fluoride
(<difference> 19 grams/mole) by the molecular weight of the compound
(e.g., the molecular weight of sodium fluoride = 42 grams/mole).
Sodium fluoride contains 45% elemental fluoride (19/42 x 100 =
45%).
\2\ Numbers in brackets refer to documents listed at the end of
this notice.
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Many dental products also contain fluorides, but at lower levels.
[[Page 61929]]
Prescription dental products are available with fluoride contents of
0.125-0.5 mg/ml for drops, 0.5-1 mg per tablet, 1 mg per lozenge, 0.1-
0.9 mg/g for topical rinses (0.01-0.09 percent and 5 mg/g (0.5 percent)
for topical gels. Prescription vitamin preparations are also available
containing 0.25 to 1 mg elemental fluoride per ml. The highest
concentration of elemental fluoride in any such dental product
available over-the-counter (``OTC'') is 0.15 percent for pastes and
powders and 0.5 percent for liquids or gels. In contrast, some
household products, particularly metal cleaners and rust removers
containing hydrofluoric acid and/or soluble fluoride salts, can have as
much as 57 percent elemental fluoride. In general, the concentrations
of elemental fluoride in household cleaners and surface preparation
agents are 10 to 1,000-fold higher than concentrations found in dental
products.[2]
2. Relevant Statutory and Regulatory Provisions
The Poison Prevention Packaging Act of 1970 (``PPPA''), 15 U.S.C.
1471-1476, authorizes the Commission to establish standards for the
``special packaging'' of any household substance if (1) the degree or
nature of the hazard to children in the availability of such substance,
by reason of its packaging, is such that special packaging is required
to protect children from serious personal injury or serious illness
resulting from handling, using, or ingesting such substance and (2) the
special packaging is technically feasible, practicable, and appropriate
for such substance.
Special packaging, also referred to as ``child-resistant (CR)
packaging,'' is (1) designed or constructed to be significantly
difficult for children under 5 years of age to open or obtain a toxic
or harmful amount of the substance contained therein within a
reasonable time and (2) not difficult for ``normal adults'' to use
properly. 15 U.S.C. 1471(4). Household substances for which the
Commission may require CR packaging include (among other categories)
foods, drugs, or cosmetics as these terms are defined in the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321). 15 U.S.C. 1471(2)(B). The
Commission has performance requirements for special packaging. 16 CFR
1700.15, 1700.20.
Section 4(a) of the PPPA, 15 U.S.C. 1473(a), allows the
manufacturer or packer to package a nonprescription product subject to
special packaging standards in one size of non-CR packaging only if the
manufacturer (or packer) also supplies the substance in CR packages of
a popular size, and the non-CR packages bear conspicuous labeling
stating: ``This package for households without young children.'' 15
U.S.C. 1473(a), 16 CFR 1700.5.
3. Existing Requirements for Fluoride-Containing Products
The Commission currently requires CR packaging for oral
prescription drugs with fluoride, but it exempts those in liquid or
tablet form that contain no more than 264 mg of sodium fluoride
(equivalent to 120 mg fluoride) per package. 16 CFR 1700.14(10)(vii).
In 1977, the Commission first exempted aqueous solutions of sodium
fluoride at that level. In 1980, in response to a petition, the
Commission extended the exemption to include liquid and tablet forms.
When it issued the exemption, the Commission believed that drugs with
sodium fluoride below that level would not cause serious personal
injury or illness to children under 5 years of age. The Commission
based this decision on the lack of serious adverse human experience
associated with such drugs at that time. The level was also partly
based on a recommendation by the American Dental Association that no
more than 264 mg of sodium fluoride should be dispensed at one time. 45
FR 78630. Also at that time, the Food and Drug Administration (``FDA'')
had determined that an acutely toxic dose of sodium fluoride for a 25
pound (<difference> 11.4 kg) child was in the range of 50 to 250 mg/kg
(equivalent to <difference> 23 to 113 mg/kg of elemental fluoride) (42
FR 62363). As discussed below, the Commission is proposing a new level
that is based on current information concerning the toxicity of
fluoride and would be consistent with the proposed CR requirement for
fluoride-containing household products.
The FDA limits OTC packages of toothpaste and tooth powder to no
more than 276 mg total elemental fluoride per package. 21 CFR 310.545.
However, preventative treatment rinses and gels sold OTC must contain
no more than 120 mg total elemental fluoride per package. 21 CFR
355.10.
B. Toxicity of Fluoride
Most available toxicity information on fluoride relates to acute
toxicity of hydrofluoric acid (``HF''). However, other water soluble
fluoride-containing compounds can cause fluoride poisoning. The
fluoride ion is systemically absorbed almost immediately. It is highly
penetrating and reactive and can cause both systemic poisoning and
tissue destruction. Fluoride ions, once separated from either HF or
fluoride salts, penetrate deep into tissues, causing burning at sites
deeper than the original exposure site. The process of tissue
destruction can continue for days.[2]
Systemic fluoride poisoning after ingestion or inhalation occurs
very rapidly as the fluoride is absorbed into the gastrointestinal
(``GI'') tract and lungs. Systemic fluoride poisoning can also result
from dermal exposure if the exposure is massive or the skin barrier has
been destroyed, as with severe burns. Fluoride absorption can produce
hyperkalemia (elevated serum potassium), hypocalcemia (lowered serum
calcium), hypomagnesemia (lowered serum magnesium), and metabolic and
respiratory acidosis. These disturbances can then bring on cardiac
arrhythmia, respiratory stimulation followed by respiratory depression,
muscle spasms, convulsions, central nervous system (``CNS'')
depression, possible respiratory paralysis or cardiac failure, and
death. Fluoride may also inhibit cellular respiration and glycolysis,
alter membrane permeability and excitability, and cause neurotoxic and
adverse GI effects.[2]
When exposure is through inhalation, fluorides can cause severe
chemical burns to the respiratory system. Inhalation can result in
difficulty breathing (dyspnea), bronchospasms, chemical pneumonitis,
pulmonary edema, airway obstruction, and tracheobronchitis. The
severity of burns from dermal absorption can vary depending on the
concentration of fluoride available, duration of the exposure, the
surface area exposed, and the penetrability of the exposed tissue.
Dermal exposure to 6 to 10 percent HF is the lowest concentration range
known to cause skin injury in humans. Destruction of tissue under the
skin may occur, as may decalcification and erosion of bone. Death from
systemic fluoride toxicity has resulted from dermal exposure to 70
percent HF over 2.5 percent of the body surface.[2]
Ocular exposure can result in serious eye injury. Exposure to
concentrations of 0.5 percent can lead to mild conjunctivitis and
greater concentrations can lead to progressively severe results such as
immediate corneal necrosis (20 percent solution).
Ingestion of fluoride can result in mild to severe GI symptoms.
Reports suggest that ingesting 3 to 5 milligrams per kilogram of
fluoride causes vomiting, diarrhea, and abdominal pain. Ingestion of
more than 5 mg/kg may produce systemic toxicity. A retrospective poison
control center study of fluoride ingestions reported
[[Page 61930]]
that symptoms, primarily safely tolerated GI symptoms that tended to
resolve within 24 hours, developed following ingestions of 4 to 8.4 mg/
kg of fluoride.[2]
According to the medical literature, a safely tolerated dose
(``STD'') and a certainly lethal dose (``CLD'') were determined from
600 fluoride poisoning deaths. The CLD was determined to be 32 to 64
mg/kg and the STD was estimated at one fourth that, or 8 to 16 mg/kg.
These values were statistically determined and do not correspond to the
actual lowest toxic or lethal levels of fluoride. The lowest documented
lethal dose for fluoride is 16 mg/kg in a 3-year-old child. There were
complicating factors in this death. The child may have taken other
medications and he suffered from Crohn's disease (an inflammatory
disorder of the GI tract) that may have contributed to his death.[2]
C. Injury Data
Medical Literature
There are many reports in the medical literature of deaths and
injuries involving fluoride-containing products. A retrospective study
conducted by the American Association of Poison Control Centers
(``AAPCC'') of hydrofluoric acid burns from rust stain removers applied
to clothing found 619 such cases in 1990. Five of these required
hospitalization. Some of the burns occurred even after the clothing had
been washed.[2]
Other reports included that of a 14-month-old child who developed
hypocalcemia and hyperfluoridemia (elevated blood fluoride level) and
went into cardiac arrest after exposure to a rust remover containing
HF. A 2\1/2\-year-old child developed respiratory failure and repeated
episodes of ventricular tachycardia (rapid heart beat) and fibrillation
after ingesting a laundry sour (used in laundry operations to
neutralize alkalis or decompose hypochlorite bleach) with sodium
fluosilicate. A 28-year-old man died after accidentally drinking floor
polish that contained fluosilicate. A 56-year-old man died after
ingesting a spoonful of glass etching cream (20% ammonium bifluoride
and 13% sodium bifluoride). He had severe burns in his esophagus and
stomach, and he suffered cardiac arrest 5 hours after the ingestion.[2]
CPSC Databases
CPSC has several databases for poison incidents. The staff reviewed
cases from 1988 to May 1997 in the National Electronic Injury
Surveillance System (``NEISS''), the Injury or Potential Injury
Incident (``IIPI'') files, Death Certificate (``DCRT'') database, and
In-Depth-Investigation (``INDP'') files. From 1988 to 1996, NEISS had
reports of 31 incidents involving products documented to contain
fluoride. Two of these were accidental ingestions by children under 5
years old. Most other injuries involved chemical burns of the hands.[2]
The INDP files contain numerous injury reports. For example, a 50-
year-old woman was using a water stain remover with 6 percent HF when
it leaked through her rubber gloves and to her skin. She developed
intense pain 4 hours later when the fluoride ion penetrated through to
the bones of her forearm. Four months after the incident she had only
partial use of her arm and hand. In another case, an 18-year-old man
developed second and third degree burns on his hands after exposure to
an automobile water spot remover with HF. His fingers became
permanently flexed from damage to the muscle and connective tissue. A
20-year-old male died of cardiac arrest after ingesting one to two
ounces of a wheel cleaner with fluoride.[2]
Three reports in the INDP files involve children under 5 years old
who died after ingesting fluoride-containing products. A three-year-old
child ingested an unknown product with HF. The second case involved a
2-year-old child who ingested a toilet bowl stain remover that
contained 15.9 percent ammonium bifluoride. The most recent case was an
18-month-old child who ingested an unknown amount of air conditioner
coil cleaner with 8 percent HF and 8 percent phosphoric acid.[2]
Since 1995, there have been six additional reports of fluoride
poisoning in children under 5 years of age from the wheel cleaning
product involved in the death of the 20-year-old man described above.
The product contains ammonium bifluoride and ammonium fluoride salts,
reportedly containing at least 15 percent fluoride. Before December,
1996, it was marketed for household use in non-CR packaging. Since that
date it has been packaged in CR packaging, and in September 1997 it was
recalled by the manufacturer.[2]
AAPCC Data
The staff reviewed AAPCC ingestion data involving children under 5
years old and products known to, or that may, contain fluoride. (The
actual number of fluoride exposures cannot be determined because some
products that contain fluoride are not identified as such and therefore
may be coded to generic categories such as acidic cleaning products or
other unknown cleaning products.) From 1993 to 1995, there were no
reported fatalities in this age group. Out of a total of 499 exposures
to products known to contain HF, there were 2 major <SUP>3</SUP>
outcomes and 24 moderate <SUP>4</SUP> outcomes. The AAPCC data also
show 23 major outcomes and 188 moderate outcomes for other acid
household products. Some of these may have contained fluoride. The
frequency of injury for dental treatments was much lower than that for
household products containing HF. Of approximately 23,000 exposures to
such dental products, there were 34 moderate outcomes, and the only
documented major outcome was a miscoded incident where the child
experienced an allergic reaction to the product rather than systemic
toxicity from an overdose.[2]
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\3\ Major outcome--The patient exhibited signs or symptoms which
were life-threatening or resulted in significant residual disability
or disfigurement.
\4\ Moderate outcome--The patient exhibited signs and symptoms
that were more pronounced, more prolonged, or more of a systemic
nature. Usually some form of treatment was required. Symptoms were
not life-threatening and the patient had no residual disability or
disfigurement.
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The staff also compiled data from AAPCC annual reports for all ages
and all routes of exposure for the years 1985 to 1995. During this time
period, there were about 25,000 exposures to products containing HF. Of
these, 2,881 resulted in moderate outcomes and 275 in major outcomes.
There were also injuries from dental products, fluoride mineral/
electrolyte products, and vitamins with fluoride. A total of 18 deaths
were reported in the HF category. Two deaths involved children under 5
years old. One ingested an ammonium bifluoride toilet stain remover
(described above) and the other child died after ingesting a toilet
cleaner with HF. Generally, these AAPCC data suggest that household
products with HF pose a more serious risk of injury than other classes
of fluoride products. Moderate to serious outcomes developed in 12.8
percent of the exposures to HF compared to only 0.4 percent of the
exposures to anticaries products.[2]
D. Level of Regulation for Household Products Containing Fluoride
The Commission is proposing a rule that requires special packaging
for household products containing more than the equivalent of 50 mg of
elemental fluoride and more than the equivalent of 0.5 percent
elemental fluoride on a weight-to-volume (``w/v'') basis for liquids or
a weight-to-weight (``w/w'') basis for non-liquids.[1&2] The Commission
is especially interested in obtaining information and receiving
[[Page 61931]]
comments on the uses and marketing patterns of glass etching creams.
There is no well defined lethal dose for fluoride. In the medical
literature, one source cites a minimum lethal dose in humans of 71 mg/
kg and another specifies a lethal oral dose in the range of 70 to 140
mg/kg. The staff considers these values too high based on documented
cases of fluoride toxicity. There is one documented death from
ingestion of 16 mg/kg fluoride, but as discussed above, other medical
factors may have contributed to that death. Most evidence suggests that
the lower limit of the calculated certainly lethal dose (CLD) of 32 mg/
kg is a reasonable estimate for a minimum lethal dose.[2]
Similarly, there is no established toxic dose for fluoride.
Generally, greater than 6 percent HF can cause dermal burns and more
than 0.5 percent can lead to serious eye injury. Several reports
suggest ingestion of 3 to 5 mg/kg produces symptoms and that more than
5 mg/kg (50 mg in a 10 kg child) can produce systemic toxicity.
Additionally, some medical professionals advise medical observation
following ingestions of more than 5 to 8 mg/kg. Based on this
information, the Commission proposes a level for regulation that would
include all household products with more than 50 mg of elemental
fluoride and more than 0.5 percent elemental fluoride on a w/v basis
for liquids or a w/w basis for non-liquids. There is no evidence that
50 mg or less of elemental fluoride or concentrations less than 0.5
percent cause serious systemic toxicity or serious burns. [1&2]
E. Level of Regulation for Oral Prescription Drugs Containing
Sodium Fluoride
Based on the toxicity information discussed above, the Commission
believes that the current exemption for oral prescription drugs with no
more than 264 mg of sodium fluoride should be modified. To be
consistent with the proposed level for household products containing
fluoride, the Commission is proposing that the level for the oral
prescription drug exemption be changed to allow no more than the
equivalent of 50 mg of elemental fluoride (110 mg sodium fluoride) per
package and no more than a concentration of 0.5 percent elemental
fluoride on a w/v basis for liquids or a w/w basis for non-liquids. The
proposed level provides a safety factor to protect sensitive
individuals.[1&2]
The Commission does not believe that changing the level of
exemption for prescription drugs containing sodium fluoride will impact
any of the currently exempted dental products with more than 50 mg of
fluoride because these products have 0.5 percent or less fluoride.
There is no evidence that any of these products have caused serious
injury. The Commission proposes modifying the exemption level so that
it is consistent with the regulated level proposed for household
products containing fluoride.[1]
F. Statutory Considerations
1. Hazard to Children
As noted above, the toxicity data concerning children's ingestion
of fluoride demonstrate that fluoride can cause serious illness and
injury to children. Moreover, it is available to children in common
household products. Although some products currently use CR packaging,
others do not. The Commission preliminarily concludes that a regulation
is needed to ensure that products subject to the regulation will be
placed in CR packaging by any current as well as new
manufacturers.[1&2]
The same hazard posed to children by toxic amounts of fluoride in
household products also exists from such levels of fluoride in oral
prescription drugs. Therefore, the Commission is proposing to modify
the existing exemption for such drugs with sodium fluoride to reflect
current toxicity data and be consistent with the proposed level for
fluoride-containing household products.[1&2]
Pursuant to section 3(a) of the PPPA, 15 U.S.C. 1472(a), the
Commission preliminarily finds that the degree and nature of the hazard
to children from handling or ingesting fluoride is such that special
packaging is required to protect children from serious illness. The
Commission bases this finding on the toxic nature of these products,
described above, and their accessibility to children in the home.
2. Technical Feasibility, Practicability, and Appropriateness
In issuing a standard for special packaging under the PPPA, the
Commission is required to find that the special packaging is
``technically feasible, practicable, and appropriate.'' 15 U.S.C.
1472(a)(2). Technical feasibility may be found when technology exists
or can be readily developed and implemented by the effective date to
produce packaging that conforms to the standards. Practicability means
that special packaging complying with the standards can utilize modern
mass production and assembly line techniques. Packaging is appropriate
when complying packaging will adequately protect the integrity of the
substance and not interfere with its intended storage or use.[4]
Some OTC fluoride-containing household products are packaged in
containers with non-CR continuous threaded closures. The Commission
also is aware of such products packaged in aerosols and mechanical
pumps. Various types and designs of senior friendly CR packaging can be
readily obtained that would be suitable for fluoride-containing
products.[3&4]
Two manufacturers currently use senior-friendly continuous threaded
CR packaging for their fluoride-containing household products. Another
manufacturer uses a senior-friendly trigger mechanical pump mechanism
for its product. This shows that these types of CR packages are
technically feasible, practicable and appropriate for fluoride-
containing products. The Commission knows of at least one fluoride
product that uses a non-CR aerosol package. The manufacturer of another
regulated product is currently using a senior-friendly CR aerosol
overcap. Thus, this kind of CR packaging could be used for fluoride-
containing products. Finally, various designs of senior-friendly snap
type reclosable CR packaging that would be appropriate for non-liquid
fluoride-containing products are available. Thus, appropriate senior-
friendly CR packaging is available for products marketed in continuous
threaded, snap, aerosols, and trigger spray packaging.[4] Therefore,
the Commission concludes that CR packaging for fluoride-containing
products is technically feasible, practicable, and appropriate.
3. Other Considerations
In establishing a special packaging standard under the PPPA, the
Commission must consider the following:
a. The reasonableness of the standard;
b. Available scientific, medical, and engineering data concerning
special packaging and concerning childhood accidental ingestions,
illness, and injury caused by household substances;
c. The manufacturing practices of industries affected by the PPPA;
and
d. The nature and use of the household substance. 15 U.S.C.
1472(b).
The Commission has considered these factors with respect to the
various determinations made in this notice, and preliminarily finds no
reason to conclude that the rule is unreasonable or otherwise
inappropriate.
G. Effective Date
The PPPA provides that no regulation shall take effect sooner than
180 days or later than one year from the date such
[[Page 61932]]
final regulation is issued, except that, for good cause, the Commission
may establish an earlier effective date if it determines an earlier
date to be in the public interest. 15 U.S.C. 1471n.
Senior-friendly special packaging is currently commercially
available for most types of CR packaging. Aerosol and mechanical pump
packages should be commercially available in senior-friendly CR designs
within nine months of a final rule.[1,4 & 5] Thus, the Commission
proposes that a final rule would take effect nine months after
publication of the final rule.
Currently available information indicates that full commercial
availability for senior-friendly mechanical pump packages and aerosol
overcap packages could take from 9 to 12 months from the date a final
rule is issued. If comments on this proposal indicate that
manufacturers using mechanical pump packages and aerosol overcap
packages need more than 9 months to comply with the rule, the
Commission may (1) specify a 1-year effective date for these types of
packages only, or (2) provide that manufacturers may request a stay of
enforcement so they can market their products in conventional packaging
for the minimum period needed to obtain an adequate supply of senior-
friendly packaging.
A final rule would apply to products that are packaged on or after
the effective date.
H. Regulatory Flexibility Act Certification
When an agency undertakes a rulemaking proceeding, the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., generally requires the agency to
prepare proposed and final regulatory flexibility analyses describing
the impact of the rule on small businesses and other small entities.
Section 605 of the Act provides that an agency is not required to
prepare a regulatory flexibility analysis if the head of an agency
certifies that the rule will not have a significant economic impact on
a substantial number of small entities.
The Commission's Directorate for Economic Analysis prepared a
preliminary assessment of the impact of a rule to require special
packaging for household products containing fluoride with more than 50
mg elemental fluoride and more than 0.5 percent elemental fluoride (w/v
or w/w). The staff also considered the impact of a rule modifying the
current exemption for oral prescription drugs containing sodium
fluoride so that it would be consistent with the level proposed for
household products.[3]
This assessment reports that the staff is aware of 25 suppliers of
products that are in categories of products that may contain fluorides.
Fourteen of these companies may be small businesses. It is unclear
which of these products actually contain fluorides and are marketed
directly to consumers rather than commercial markets. The staff is also
aware of 40 suppliers of automotive and household cleaning chemicals
and products. Some of these products may contain fluoride.[3] The
Commission requests comments from companies that supply fluoride-
containing household products. The Commission is particularly
interested in comments and information on the likely effect of this
proposed rule on small businesses.
Several consumer products containing fluoride are already in CR
packaging. For example, senior friendly packaging is used by a small
business marketer of a fluoride-containing rust remover packaged in a
plastic container with a continuous turn closure. Another small
business, marketing a fluoride-containing glass etching cream, also
uses senior-friendly CR packaging. However, the small business marketer
of another glass etching product is not currently using CR packaging. A
variety of types of senior friendly CR packaging that would be suitable
for such products are readily available at prices competitive with non-
CR packaging. Similarly, of the three known marketers of fluoride-
containing wheel cleaners, one (a large manufacturer) is using CR
packaging, while another (a small business) is not. Senior-friendly
trigger sprays like those used for this product are available. The
incremental cost of a CR trigger is not likely to be large relative to
the retail cost of the product.[3]
Based on this assessment, the Commission concludes that the
proposed requirement for fluoride-containing household products would
not have a significant impact on a substantial number of small
businesses or other small entities.
Furthermore, the proposed modification in the level for exemption
of oral prescription drugs containing sodium fluoride is not likely to
affect any currently available prescription drugs, and if such drugs
should become available in the future appropriate CR packaging is
readily available at prices competitive with non-CR packaging.
Therefore, the Commission concludes that the proposed modification to
the exemption for oral prescription drugs containing sodium fluoride
would not have a significant impact on a substantial number of small
businesses or other small entities.
I. Environmental Considerations
Pursuant to the National Environmental Policy Act, and in
accordance with the Council on Environmental Quality regulations and
CPSC procedures for environmental review, the Commission has assessed
the possible environmental effects associated with the proposed PPPA
requirements for fluoride-containing products.
The Commission's regulations state that rules requiring special
packaging for consumer products normally have little or no potential
for affecting the human environment. 16 CFR 1021.5(c)(3). Nothing in
this proposed rule alters that expectation. Therefore, because the rule
would have no adverse effect on the environment, neither an
environmental assessment nor an environmental impact statement is
required.
J. Executive Orders
According to Executive Order 12988 (February 5, 1996), agencies
must state in clear language the preemptive effect, if any, of new
regulations.
The PPPA provides that, generally, when a special packaging
standard issued under the PPPA is in effect, ``no State or political
subdivision thereof shall have any authority either to establish or
continue in effect, with respect to such household substance, any
standard for special packaging (and any exemption therefrom and
requirement related thereto) which is not identical to the [PPPA]
standard.'' 15 U.S.C. 1476(a). A State or local standard may be
excepted from this preemptive effect if (1) the State or local standard
provides a higher degree of protection from the risk of injury or
illness than the PPPA standard; and (2) the State or political
subdivision applies to the Commission for an exemption from the PPPA's
preemption clause and the Commission grants the exemption through a
process specified at 16 CFR Part 1061. 15 U.S.C. 1476(c)(1). In
addition, the Federal government, or a State or local government, may
establish and continue in effect a non-identical special packaging
requirement that provides a higher degree of protection than the PPPA
requirement for a household substance for the Federal, State or local
government's own use. 15 U.S.C. 1476(b).
Thus, with the exceptions noted above, the proposed rule requiring
CR packaging for household products containing fluoride above the
regulated level and modifying the exemption level for oral prescription
drugs with sodium fluoride would preempt non-identical
[[Page 61933]]
state or local special packaging standards for such fluoride containing
products.
In accordance with Executive Order 12612 (October 26, 1987), the
Commission certifies that the proposed rule does not have sufficient
implications for federalism to warrant a Federalism Assessment.
List of Subjects in 16 CFR Part 1700
Consumer protection, Drugs, Infants and children, Packaging and
containers, Poison prevention, Toxic substances.
For the reasons given above, the Commission proposes to amend 16
CFR part 1700 as follows:
PART 1700--[AMENDED]
1. The authority citation for part 1700 continues to read as
follows:
Authority: Pub. L. 91-601, secs. 1-9, 84 Stat. 1670-74, 15
U.S.C. 1471-76. Secs 1700.1 and 1700.14 also issued under Pub. L.
92-573, sec. 30(a), 88 Stat. 1231, 15 U.S.C. 2079(a).
2. Section 1700.14 is amended to revise paragraph (a)(10)(vii) and
to add paragraph (a)(27) to read as follows (although unchanged, the
introductory text of paragraphs (a) and (10) are included below for
context):
Sec. 1700.14 Substances requiring special packaging.
(a) Substances. The Commission has determined that the degree or
nature of the hazard to children in the availability of the following
substances, by reason of their packaging, is such that special
packaging meeting the requirements of Sec. 1700.20(a) is required to
protect children from serious personal injury or serious illness
resulting from handling, using, or ingesting such substances, and the
special packaging herein required is technically feasible, practicable,
and appropriate for these substances:
* * * * *
(10) Prescription drugs. Any drug for human use that is in a dosage
form intended for oral administration and that is required by Federal
law to be dispensed only by or upon an oral or written prescription or
a practitioner licensed by law to administer such drug shall be
packaged in accordance with the provisions of Sec. 1700.15 (a), (b),
and (c), except for the following:
* * * * *
(vii) Sodium fluoride drug preparations including liquid and tablet
forms, containing not more than 110 milligrams of sodium fluoride (the
equivalent of 50 mg of elemental fluoride) per package and not more
than a concentration of 0.5 percent elemental fluoride on a weight-to-
volume basis for liquids or a weight-to-weight basis for non-liquids
and containing no other substances subject to this Sec. 1700.14(a)(10).
* * * * *
(27) Fluoride. Household substances containing more than the
equivalent of 50 milligrams of elemental fluoride per package and more
than the equivalent of 0.5 percent elemental fluoride on a weight-to-
volume basis for liquids or a weight-to-weight basis for non-liquids
shall be packaged in accordance with the provisions of Sec. 1700.15
(a), (b) and (c).
Dated: November 17, 1997.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
List of Relevant Documents
1. Briefing memorandum from Jacqueline Ferrante, Ph.D., EH, to
the Commission, ``Proposed Rule to Require Child-Resistant Packaging
for Household Products with Fluoride,'' September 30, 1997.
2. Memorandum from Susan C. Aitken, Ph.D., EH, to Jacqueline
Ferrante, Ph.D., EH, ``Toxicity of Household Products Containing
Fluoride,'' August 4, 1997.
3. Memorandum from Marcia P. Robins, EC, to Jacqueline Ferrante,
Ph.D., EH, ``Market Data, Economic Considerations and Environmental
Effects of a Proposal to Require Child-Resistant Packaging for
Household Products Containing Fluoride,'' June 20, 1997.
4. Memorandum from Charles Wilbur, EH, to Jacqueline Ferrante,
Ph.D., EH, ``Technical Feasibility, Practicability, and
Appropriateness Determination for the Proposed Rule to Require
Child-Resistant Packaging for OTC Products Containing Fluoride,''
June 27, 1997.
[FR Doc. 97-30555 Filed 11-19-97; 8:45 am]
BILLING CODE 6355-01-P